This invention relates to a stable dry powder formulation of a hydrated cephalosporin, e.g., ceftibuten di-or trihydrate, which is suitable for use as a pharmaceutical composition in the form of an oral suspension product to treat bacterial infections..
U.S. Pat. No. 4,634,697 discloses ceftibuten, (+)-(6R,7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-4-carboxycrotonamido]-8-oxo-5-t hia-1-azabicyclo[4.2.0]-oct-2-ene-2-carboxylic acid, a cephalosporin antimicrobial agent which exhibits antibacterial activity against a wide range of gram-negative and certain gram-positive bacteria.
U.S. Pat. Nos. 4,933,443 and 4,812,561 disclose that ceftibuten is stable in a (di-or-tri-)hydrate crystalline form and that a pharmaceutically effective amount of the (di or tri)hydrate can be incorporated into specially sealed hard gelatin capsules for oral administration.
There is still a need for a stable dry powder ceftibuten formulation suitable for suspension in water for oral administration. There is also a need for a simple efficient process for making such a stable dry powder ceftibuten formulation having an extended shelf life at temperatures of 25.degree. C. or less.